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B. Braun Wants AP Ratings for Some Drugs

[ Price : $8.95]

B. Braun asks FDA to assign AP therapeutic equivalence codes to some of its injectable products in the Orange Book.

Ossio Gains Clearance for Hammertoe Fixation

[ Price : $8.95]

FDA clears an Ossio 510(k) for its OssioFiber Hammertoe Fixation System for maintenance of alignment and fixation of bone fracture...

Fecal Microbiota for Transplant Safety Alert

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FDA issues a safety alert on potential infection risk from using fecal microbiota for transplantation to treat C. difficile infect...

FDA Delays Foreign Inspections Through April

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Alston & Bird reviews provisions in FDAs announcement postponing foreign inspections and offers guidance to regulated industry.

Fast Track for Jardiance in Kidney Disease

[ Price : $8.95]

FDA grants Boehringer Ingelheim and Eli Lilly a fast track designation for Jardiance (empagliflozin) and its use to reduce the ris...

Virus Testing is a Failure: Health Officials

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A day after FDA commissioner Stephen Hahn was criticized during a 3/11 hearing about delays in testing amid the coronavirus outbre...

Biocon Limited FDA-483

[ Price : $8.95]

FDA releases the FDA-483 with five observations from an inspection at Indias Biocon Limited API manufacturer.

510(k) Third Party Review Guidance Out

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FDA issues a guidance on its implementation of the 510(k) third party review program.

Maitland Labs FDA-483

[ Price : $8.95]

FDA releases the FDA-483 with seven inspection observations from the Maitland Labs of Central Florida outsourcing facility.

CDER Adds eSubmission Standards

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Federal Register notice: CDER has announced that it will begin supporting new e-submission standards for Animal Rule submissions e...